A New Vision for Risk-Driven QMS with qmsWrapper

Today, we’re thrilled to announce the latest version of qmsWrapper—a big little QMS system that doesn’t take the risk out but captures it.

For existing customers, rest assured: nothing you’re doing now will change. Your current processes and workflows remain fully supported. What’s new is the opportunity to adopt a fully risk-driven, Event-based QMS flows that distributes work more evenly across your team, making compliance easier, more effective, and more engaging.

For new customers, this is your chance to embrace a QMS system designed to make compliance effortless, searchable, and trackable.

Let’s dive in.

 

The Problem: Compliance is a Battle

Let’s face it: compliance is often seen as a battle between regulation and the unwilling. For non-QMS professionals—developers, engineers, customer support teams—it’s boring, tedious, and time-consuming. Changes, deviations, non-conformities, and feedback often get ignored or pushed aside because capturing and documenting these QMS Events feels like a chore.

The result?

• QMS Events are hoarded in paper notebooks, sticky notes, or buried in obscure files.
• Critical details are forgotten, lost, or never addressed.
• Regulatory bodies’ pivot to risk-based QMS adds even more pressure.

Until now.

 

The Solution: qmsWrapper Makes QMS Easy Again

The latest version of qmsWrapper is designed to directly address these challenges through automated Event-driven-risk –based QMS flows. It’s all about making QMS:

• Easy to Capture: Simplify the process of documenting QMS Events.
• Easy to Identify: Quickly categorize and prioritize Events.
• Easy to Track: Maintain a clear, searchable log of all Events.
• Easy to Follow Up: Automate risk assessments and workflows.

 

How It Works: The Event

At the heart of this update is the Event, a centralized hub for capturing and managing Events.

It starts with four predefined, ready-to-use event types:

• Change
• Deviation
• Non-Conformity
• Feedback

Each of these can be launched in a single click—eliminating delays and missed entries. We’ve designed them to reflect real-life workflows and ensure consistent data capture across teams.

Want more flexibility?
qmsWrapper—the most flexible software on the planet—has you covered. We didn’t stop at building a predefined event flow that locks customers in; we went further.

With qmsWrapper, any custom form can be used as an Event, giving you complete control over what you track. While we recommend starting with our built-in Event Form—fully editable and optimized with pre-set automation—you’re free to build your own Event Logic around the processes that matter most to your organization.

 

What Else Is New: Build Your QMS Around Your Processes

Beyond Events, this release introduces a suite of powerful tools to help you build a smarter, more responsive QMS.

 

Event Capturing: Predefined, But Fully Yours

The Event Capturing framework automates your most common workflows using four core scenarios: Change, Deviation, Non-Conformity, and Feedback. Your organization has unique processes? —you can easily customize and add organization-specific Events and flows to ensure the system reflects your exact way of working.

Why It’s Game-Changing

• Prefilled Forms in Smart Workflows
  Events and forms can be connected in a defined flow—once data is entered, predefined-key fields are automatically carried forward to the next step. This reduces manual entry, minimizes errors, and saves time.
• Dynamic Rule-Based Automation
  The system adapts in real time—next steps are triggered based on user inputs, ensuring each action follows the correct path without guesswork.
• Action-Ready Events
  With built-in automation, every Event becomes more than just a record—it’s a trigger for structured follow-up actions and automated Risk Evaluation, turning insight into immediate response.

Download the "Create Event" PDF to explore how this new feature simplifies capturing and managing QMS Events.

 

Actions: From Static Forms to Smart Workflows

Forms are no longer just containers of information—they're smart. With Actions, you can turn any form into a live decision-making engine.

Highlights:

• Hold Actions: Automations can now wait until a previous action is complete—perfect for approvals or task sequences.
• Conditional Triggers: Set up Actions that can be activated only if specific form conditions are met.
• Approval Chains: Launch approval processes automatically based on input data within the form.

Why It Matters

• Eliminates Data Duplication
  Information entered once can automatically populate across multiple forms and systems (e.g., risk entries), reducing redundant data entry.
• Ensures Data Completeness
  Mandatory fields and standardized formats ensure that no critical information is skipped, leading to consistent and comprehensive submissions.
• Improves Accuracy
  Automated logic replaces manual processes, significantly reducing the risk of human error.
• Boosts Speed and Efficiency
  Say goodbye to sticky notes and scattered information. Even brief, informal notes are captured and organized in the system. Managers can easily pick up where others left off, ensuring smooth handovers and timely follow-up actions. With predefined Event flows, your operations become a no-brainer—speed and efficiency follow naturally.

 

Unified Forms: Smart, Flexible, and Actionable

Say goodbye to managing different types of forms for each use case. Now, every form is both standalone and actionable:

• Start with a custom form.
• Convert it into a task, if needed.

Why It’s Better:

• Saves Time: No duplicate form types or extra setup.
• Increases Flexibility: Any form can be used across departments.
• Enhances Collaboration: Everyone sees the same structure, same expectations.

 

Streamlined Tag Management: One System to Tag It All

All tags are now unified under a single system and managed directly from the QMS module. You can tag:

• Tasks
• Documents
• Forms
• Form Templates
• Process Templates

Why It’s Better:

• Simplifies categorization
• Improves filtering
• Keeps everything connected in one clean structure

 

Hazard Log: Centralized Risk Oversight

The Hazard Log aggregates risk-related data into three key categories aligned with ISO 14971, DCB0129, and MDR/IVDR requirements:

• Design: Tracks inherently safe design measures (e.g., fail-safe mechanisms).
• Training: Highlights user safety training requirements.
• Business Process: Monitors protective controls in manufacturing (e.g., sterilization protocols).

Why It’s Beneficial:

• Automated data integration eliminates silos.
• Prioritized actions ensure timely risk mitigation.

 

Custom Logs: QMS on Your Terms

Not every team tracks the same things. That’s why we introduced Custom Logs—personalized dashboards that show you only what matters most.

• Create dedicated logs for audits, supplier evaluations, onboarding, or any recurring process.
• Add any form as a tab in your custom log and monitor its lifecycle in real time.
• Build your own event lists, tailored to your workflows.

Why It Matters:

• One-click access to progress updates.
• Custom views for each role or department.
• Simplified tracking across long, multi-step processes.

 

The Best Part: It Changes Nothing (Unless You Want It To)

For existing customers, this update is entirely optional. You can continue using qmsWrapper as you always have, or gradually adopt the new functionality at your own pace.

For new customers, this is your opportunity to start with a QMS system designed to make compliance effortless, engaging, and effective.

 

Goals

This update aligns your QMS with MDR and QMSR, emphasizing risk management. The goal is simple: ensure every team member contributes to the QMS.

• Capture Events Effortlessly: From design changes to customer feedback, every event is documented and tracked.
• Automate Risk Assessments: Ensure risks are identified, assessed, and mitigated.
• Streamline Compliance: Meet regulatory requirements with minimal manual effort.
• Build a Culture of Accountability: QMS becomes part of daily operations—not a separate chore.

 

Discover how qmsWrapper streamlines compliance. Schedule a demo today!
Already a user? Contact contact@qmswrapper.com for a free training session and make the most of what’s new.